© 2014 by Boston Scientific Corporation or its affiliates. All rights reserved EP-281802-AB DEC2014 Blazer ™ Family of Ablation Catheters Predictable

© 2014 by Boston Scientific Corporation or its affiliates. All rights reserved EP-281802-AB DEC2014

Blazer™ Family of Ablation Catheters

Predictable. Dependable. Proven.

Blazer is a registered or unregistered trademark of Boston Scientific or its affiliates. All other trademarks are property of their respective owners. Navigation TipsInformation not intended for distribution in France

Information not intended for distribution in France

© 2014 by Boston Scientific Corporation or its affiliates. All rights reserved. EP-281802-AB DEC2014 - Information not intended for distribution in France

ORDERING INFORMATION

INTRODUCTIONBLAZER II

BLAZER II HTDBLAZER II XP BLAZER PRIME

COMPETITIVE INFO

CURRENT DENSITY

BLAZER OPEN-IRRIGATED

Blazer™ Predictable. Dependable. Proven.

Proven ResultsOne of the top selling therapeutic catheters. • Over 1 million

catheters sold*

Dependable PerformanceCatheter can be relied upon to perform consistently throughout long cases.• Curve retention

Predictable HandlingDesigned for consistent handling – whether mapping or delivering therapy.• Precise micro-movements• Torqueability• In-plane steering • Tip stability

*From 1999 through 2014

BLAZER

PREDICTABLE

DEPENDABLE

PROVEN

INTRODUCTION






COMPETITIVE INFO

CURRENT DENSITY


What makes a Blazer™ a BLAZER?Introduction

Steering Plate(metal)

Kevlar™ Wrap

Distal Tip

Distal Tip Detail

Handle• Tension control knob • Bi-wing steering knob• Tactile curve reference

on handle

Patented Steering Design• Only catheter with steering wires

attached to steering plate• Unique Kevlar wrap secures steering

wires around metal steering plate

Catheter Body• Woven metal braid • Steering coil

INTRODUCTION






COMPETITIVE INFO

CURRENT DENSITY


What makes a Blazer™ a BLAZER?Introduction

Distal Tip

Distal Tip Detail

Catheter Body• Woven metal braid • Steering coil

Patented Steering Design• Only catheter with steering wires

attached to steering plate• Unique Kevlar wrap secures steering

wires around metal steering plate

Design allows for precise micro-movements

Robust catheter body transmits torque delivering

excellent tip stability

Patented steering design provides in-plane steering

and curve retention throughout long cases

‘Flats’ define plane of deflection

Handle• Tension control knob • Bi-wing steering knob• Flats on handle

Steering Plate(metal)

Kevlar™ Wrap

INTRODUCTION

© 2014 by Boston Scientific Corporation or its affiliates. All rights reserved. EP-281802-AB DEC2014




COMPETITIVE INFO

CURRENT DENSITY


Blazer™ II and Blazer™ II HTDAblation Catheter

BLAZER IIBLAZER II HTD





COMPETITIVE INFO

CURRENT DENSITY


Blazer™ II and Blazer™ II HTDAblation Catheter

* From 1999 through 2014

Predictable Handling Over 25 models designed to maneuver and maintain contact in various anatomies.

Proven ResultsOver 1 million catheters sold*

Dependable PerformanceDurable construction provides curve retention throughout long cases.


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Ordering Information






COMPETITIVE INFO

CURRENT DENSITY


Blazer™ II(7F*/4mm)

Blazer™ II HTD(7F*/4mm)

Blazer Prime™

(7F*/4mm)

The Blazer™ II PlatformAVNRT & Accessory Pathway Toolsets

d=18mm^ d=25mm^ d=33mm^ d=17mm^ d=25mm^

*7F = 2.33 mm

^ Dimensions are for reference only.



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Blazer™ II XPAblation Catheter




COMPETITIVE INFO

CURRENT DENSITY


BLAZER II XP


Blazer™ II XPAblation Catheter

Predictable Handling • Assists in reaching the Isthmus and

maintaining contact• Allows for backsteering approach

Dependable Performance• Excellent curve retention to

reach and maintain contact with Isthmus.

Proven Clinical Results• The market leading large tip catheter in the

US for treating Type 1 Atrial Flutter.• Lower recurrence rates• More efficient procedures with 10mm tip• 100W available with the Maestro 3000™

Cardiac Ablation System• Greater than 70W required in 85% of

procedures

More information

More information

More information

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COMPETITIVE INFO

CURRENT DENSITY


BLAZER II XP






COMPETITIVE INFO

CURRENT DENSITY


Blazer™ II XP(8F*/8mm, 8F*/10mm)

Blazer Prime™ XP(8F*/8mm, 8F*/10mm)

The Blazer™ II XP PlatformType 1 Atrial Flutter Toolsets

*8F = 2.66 mm

^ Dimensions are for reference only.

d=33mm^d=25mm^ d=17mm^ d=25mm^

BLAZER II XP

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COMPETITIVE INFO

CURRENT DENSITY


The Blazer™ II XP is EfficientFewer RF applications, less ablation time

A typical Isthmus is approximately 3cm long1

Benefits of a 10mm vs. 8mm:• 29% fewer RF applications2

• 38% less ablation time2

1. Da Costa A, Faure E, Thevenin J, Messier M, Bernard S, Abdel K, et al. Effect of isthmus anatomy and ablation catheter on radiofrequency catheter ablation for the cavotricuspid isthmus. Circulation 2004; 110:1030-1035. (2) Petersen HH, Chen X, Pietersen A, Svendsen JH, Haunso S. Lesion dimensions during temperature-controlled radiofrequency catheter ablation of left ventricular porcine myocardium: Impact of ablation site, electrode size, and convective cooling. Circulation 1999; 99:319-325. Boston Scientific Image Library. 2. Feld G, Wharton M, Plumb V, et al. Radiofrequency catheter ablation of type 1 atrial flutter using large tip 8- or 10-mm electrode catheters and a high-output radiofrequency energy generator. J Am Coll Cardiol. 2004;43:1466-72.

10mm Tip8mm Tip

BLAZER II XP

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Back to Product Page







COMPETITIVE INFO

CURRENT DENSITY


Blazer™ II XP Ablation CatheterBlazer XP Clinical Information

Market leading ablation catheter for right sided procedures. The Data Speaks for Itself…

BLAZER II XP

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COMPETITIVE INFO

CURRENT DENSITY


Blazer™ II XP Ablation CatheterBlazer XP Clinical Information

BLAZER II XP

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COMPETITIVE INFO

CURRENT DENSITY


Blazer Prime™ Ablation Catheter

BLAZER PRIME





COMPETITIVE INFO

CURRENT DENSITY



Dependable Performance• 200% improvement in

curve retention3

Predictable Handling Through enhanced control• 70% greater pushability1

reducing the need for a long sheath• 17% greater torqueability2

• 59% greater lateral contact3

• Improved trackability4

Blazer Prime for:

Flutter AVNRT AccessoryPathways

RVOT

(1) Catheter stiffness profile/3-point bend bench testing compared Blazer Prime and Blazer II HTD™ temperature ablation catheters. Bench testing performed by Boston Scientific. N=5. Data on file. (2) Torsional rigidity (soaked) bench testing compared Blazer Prime and Blazer II HTD™ temperature ablation catheters. Bench testing performed by Boston Scientific. N=5. Data on file. (3) Curve retention/curve angle degradation bench testing compared Blazer Prime and Blazer II HTD™ temperature ablation catheters. Bench testing performed by Boston Scientific. N=5. Data on file. (4) Distal torque bench testing compared Blazer Prime and Blazer II HTD™ temperature ablation catheters. Bench testing performed by Boston Scientific. N=5. Data on file. Bench testing not necessarily predictive of clinical performance.

BLAZER PRIME


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COMPETITIVE INFO

CURRENT DENSITY



Enhanced Torqueability(Mandrel)

Enhanced Trackability (Polyimide Tubing)

Enhanced Tip Stability (Fiber Weave)

Proximal Section(70cm) Transition Zone

(5cm)Distal Section

(11cm)

Enhanced Curve Retention (Stronger Steering Plate)

BLAZER PRIME


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COMPETITIVE INFO

CURRENT DENSITY


Blazer Prime™ HTD/XP vs. Blazer™ II HTD/XP Catheter Catheter Construction

BLAZER PRIME

Material Change to Steering Plate – Higher Yield Stainless Steel

Fiber Weave

Steering Plate

Support Mandrel

Kevlar WrapProximal-to-Distal

Transition Zone

Polyimide Tubing – Improved transition

Blazer Prime™ HTD, Blazer Prime™ XP Catheter

Blazer™ II HTD, Blazer™ II XPCatheter

Proximal Section Transition Zone Distal Segment


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COMPETITIVE INFO

CURRENT DENSITY


Blazer™ Open-IrrigatedAblation Catheter



*Oley LA, Koblish J, Mirigian M, Tee SH, Harvey G, Subramaniam R. Boston Scientific, San Jose, CA. Use of high-resolution infrared thermography to analyze thermal profiles of a novel cooled RF ablation catheter. Heart Rhythm, 2009; 6(Suppl 1): p. S217) (PDM: 90526597) ORDERING

INFORMATIONINTRODUCTION


BLAZER II XP BLAZER PRIMECOMPETITIVE

INFOCURRENT DENSITY



Predictable CoolingTotal Tip Cooling™ design provides: • Greater cooling capacity*• Reduced proximal heating*• Active tip washing• Uniform external flow

Dependable Performance• Build on the bidirectional

Blazer™ Catheter platform


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COMPETITIVE INFO

CURRENT DENSITY



Bidirectional Steering

Tip Stability

Predictable Trackability and Torqueability

Micromovements

Why we think you will like it…• It’s open irrigation…on a Blazer™ Catheter platform• Tissue cooling + distal cooling + proximal cooling


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COMPETITIVE INFO

CURRENT DENSITY


Blazer Open-Irrigated Ablation Catheter Tip Electrode

Dual Cooling Chambers

Targeted Proximal Cooling

Central Cooling Lumen

Exit Flow Directed Proximally

Uniformly Cooled Electrode

Irrigation Flow

Lesion forming in tissue

Infrared Imaging

External Flow Visualization

(20W, ~30 seconds)

(17 ml/min)

Blazer™ Open-Irrigated Ablation CatheterTotal Tip Cooling™ Design

Thermal camera testing and external flow visualization completed by Boston Scientific. n = 1. Data on File. These thermal camera images are of a single catheter and may not be fully representative of all catheters. Product illustration, not actual photograph.


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COMPETITIVE INFO

CURRENT DENSITY


Blazer™ Open-Irrigated Ablation CatheterThe Blazer™ Open-Irrigated Platform

Blazer Open-Irrigated

Platform Built on the bidirectional Blazer™ Catheter Platform

Tip Design Open-irrigated with dual internal cooling chambers (7F* / 4mm)

Shaft Diameter 7.5F* shaft (8F* sheath recommended)

Electrode Spacing Quadripolar 2.5/2.5/2.5

Shaft Length 110cm and 115cm lengths (Large curve only for 115cm)

Available Curves Standard, Large and Asymmetric


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*7F = 2.33 mm; 7.5F = 2.5 mm; 8F = 2.66 mm


Blazer™ II vs. Blazer™ II XPCurrent Density




COMPETITIVE INFO

CURRENT DENSITY


CURRENT DENSITY






COMPETITIVE INFO

CURRENT DENSITY


A larger tip catheter requires higher power to reach current densities (and therefore resistive heating intensities) necessary for creating effective lesions.


>70W were required in 85% of the procedures during the atrial flutter clinical trial*

^Feld G, Wharton M, Plumb V, et al. Radiofrequency catheter ablation of type 1 atrial flutter using large tip 8- or 10-mm electrode catheters and a high-output radiofrequency energy generator. J Am Coll Cardiol. 2004;43:1466-72.

Catheter SizeElectrode Surface

AreaImpedance

(Ω)

Current Density

(amps/in2)

Power (W)

20 30 40 50 60 70 80 90 100

7F/4mm 0.050 100 8.9 10.9 12.6 14.1

8F/8mm 0.098 60 5.9 7.2 8.3 9.3 10.2 11.0 11.7 12.5 13.1

8F/10mm 0.123 50 5.1 6.3 7.3 8.1 8.9 9.6 10.3 10.9 11.5


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CURRENT DENSITY






COMPETITIVE INFO

CURRENT DENSITY


A larger tip catheter requires higher power to reach current densities (and therefore resistive heating intensities) necessary for creating effective lesions.

Catheter SizeElectrode Surface

AreaImpedance

(Ω)

Current Density

(amps/in2)

Power (W)

20 30 40 50 60 70 80 90 100

7F/4mm 0.050 100 8.9 10.9 12.6 14.1

8F/8mm 0.098 60 5.9 7.2 8.3 9.3 10.2 11.0 11.7 12.5 13.1

8F/10mm 0.123 50 5.1 6.3 7.3 8.1 8.9 9.6 10.3 10.9 11.5


>70W were required in 85% of the procedures during the atrial flutter clinical trial*

^Feld G, Wharton M, Plumb V, et al. Radiofrequency catheter ablation of type 1 atrial flutter using large tip 8- or 10-mm electrode catheters and a high-output radiofrequency energy generator. J Am Coll Cardiol. 2004;43:1466-72.


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CURRENT DENSITY


Blazer™ II XP Ablation CatheterCompetitive Information




COMPETITIVE INFO

CURRENT DENSITY


COMPETITIVE INFO






COMPETITIVE INFO

CURRENT DENSITY



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COMPETITIVE INFO






COMPETITIVE INFO

CURRENT DENSITY



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COMPETITIVE INFO






COMPETITIVE INFO

CURRENT DENSITY



The gold standard of ablation catheters for Atrial Flutter. The Data Speaks for Itself…

Proven Clinical Results


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COMPETITIVE INFO






COMPETITIVE INFO

CURRENT DENSITY



Market leading ablation catheter for right sided procedures. The Data Speaks for Itself…

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COMPETITIVE INFO





COMPETITIVE INFO

CURRENT DENSITY


Blazer™ FamilyOrdering Information







COMPETITIVE INFO

CURRENT DENSITY


Blazer Prime™ Ablation CatheterOrdering Information – Small Tip



Large Tip Ordering Information

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COMPETITIVE INFO

CURRENT DENSITY


Blazer II HTD™ Ablation CatheterOrdering Information – Small Tip



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Blazer II Ordering Information






COMPETITIVE INFO

CURRENT DENSITY


Blazer II™ Ablation CatheterOrdering Information – Small Tip




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Blazer II HTDOrdering Information






COMPETITIVE INFO

CURRENT DENSITY


Blazer Prime™ XP Ablation CatheterOrdering Information – Large Tip



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Small Tip Ordering Information






COMPETITIVE INFO

CURRENT DENSITY


Blazer II XP™ HTD Ablation CatheterOrdering Information – Large Tip



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Blazer II XPOrdering Information






COMPETITIVE INFO

CURRENT DENSITY


Blazer II XP™ Ablation CatheterOrdering Information – Large Tip



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Blazer II XP HTDOrdering Information






COMPETITIVE INFO

CURRENT DENSITY


Blazer II™ Ablation CatheterOrdering Information – Large Tip



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Small Tip Ordering Information

Blazer II HTDOrdering Information






COMPETITIVE INFO

CURRENT DENSITY


Blazer™ Open-Irrigated Ablation CatheterOrdering Information – Small Tip


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© 2014 by Boston Scientific Corporation or its affiliates. All rights reserved EP-281802-AB DEC2014

Blazer™ Family of Ablation Catheters

Predictable. Dependable. Proven.

Blazer is a registered or unregistered trademark of Boston Scientific or its affiliates. All other trademarks are property of their respective owners. Navigation Tips

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INTRODUCTION

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© 2014 by Boston Scientific Corporation or its affiliates. All rights reserved EP-281802-AB DEC2014 Blazer ™ Family of Ablation Catheters Predictable